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P458 Effectiveness of biological therapy for pouchitis and other inflammatory complications ot the pouch. And the question of a second Anti-TNF after failure? Results from the RESERVO Study of GETECCU.

Mesonero Gismero, F.(1);Zabana, Y.(2);Fernández-Clotet, A.(3);Núñez, A.(4);Caballol, B.(3);Sola, A.(4);García, M.J.(5);Bertoletti, F.(6);Mínguez, A.(7);Suris, G.(8);Casis, B.(9);Ferreiro-Iglesias, R.(10);Calafat, M.(11);Jiménez, I.(12);Miranda-Bautista, J.(13);Lamuela, L.J.(14);Fajardo, I.(15);Torrealba, L.(16);Nájera, R.(17);Sáiz, R.M.(18);González, I.(19);Vicuña, M.(20);García-Morales, N.(21);Gutiérrez, A.(22);López-García, A.(23);Benítez, J.M.(24);Rubín de Célix, C.(25);Tejido, C.(26);Brunet, E.(27);Hernández, A.(28);Suárez, C.(29);Piquqeras, M.(30);Castaño, A.(31);Ramos, L.(32);Sobrino, A.(33);Rodríguez-Grau, M.C.(34);Elosua, A.(35);Montoro, M.(36);López-Sanromán, A.(1);Barreiro-de Acosta, M.(10);

(1)Hospital Universitario Ramón y Cajal, Department of Gastroenterology, Madrid, Spain;(2)Hospital Universitari Mútua Terrassa. Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas CIBERehd., Gastroenterology, Barcelona, Spain;(3)Hospital Clínic Barcelona, Gastroenterology, Barcelona, Spain;(4)Hospital Universitario Virgen del Rocío, Gastroenterology, Sevilla, Spain;(5)Hospital Universitario Marqués de Valdecilla- IDIVAL, Gastroenterology, Santander, Spain;(6)Hospital de la Santa Creu i Sant Pau, Gastroenterology, Barcelona, Spain;(7)Hospital Universitario y Politécnico La Fe, Gastroenterology, Valencia, Spain;(8)Hospital Universitari de Bellvitge, Gastroenterology, Barcelona, Spain;(9)Hospital Universitario 12 de Octubre, Gastroenterology, Madrid, Spain;(10)Hospital Clínico Universitario Santiago, Gastroenterology, Santiago de Compostela, Spain;(11)Hospital Universitari Germans Trias i Pujol, Gastroenterology, Badalona, Spain;(12)Hospital Universitario Galdakao, Gastroenterology, Bilbao, Spain;(13)Hospital Universitario Gregorio Marañón, Gastroenterology, Madrid, Spain;(14)Hospital Universitario Miguel Servet, Gastroenterology, Zaragoza, Spain;(15)Hospital Universitari Mútua Terrassa, Gastroenterology, Barcelona, Spain;(16)Hospital Universitari Doctor Josep Trueta, Gastroenterology, Girona, Spain;(17)Hospital Universitario Río Hortega, Gastroenterology, Valladolid, Spain;(18)Hospital Universitario Burgos, Gastroenterology, Burgos, Spain;(19)Hospital Universitario Puerta de Hierro Majadahonda, Gastroenterology, Madrid, Spain;(20)Complejo Hospitalario Navarra, Gastroenterology, Pamplona, Spain;(21)Hospital Álvaro Cunqueiro, Gastroenterology, Vigo, Spain;(22)Hospital General Universitario Alicante. Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas CIBERehd. Instituto de Investigación Sanitaria y Biomédica de Alicante ISABIAL., Gastroenterology, Alicante, Spain;(23)Hospital del Mar, Gastroenterology, Barcelona, Spain;(24)Hospital Universitario Reina Sofía, Gastroenterology, Córdoba, Spain;(25)Hospital Universitario La Princesa. Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas CIBERehd. Instituto de Investigación Sanitaria Princesa IIS-IP., Gastroenterology, Madrid, Spain;(26)Complejo Hospitalario Universitario Ourense, Gastroenterology, Ourense, Spain;(27)Hospital Universitari Parc Taulí, Gastroenterology, Sabadell, Spain;(28)Hospital Universitario Nuestra Señora de Candelaria, Gastroenterology, Tenerife, Spain;(29)Hospital Universitario La Paz, Gastroenterology, Madrid, Spain;(30)Consorci Sanitari Terrassa, Gastroenterology, Barcelona, Spain;(31)Hospital Universitario Central Asturias, Gastroenterology, Oviedo, Spain;(32)Hospital Universitario de Canarias, Gastroenterology, Tenerife, Spain;(33)Hospital General Universitario Ciudad Real, Gastroenterology, Ciudad Real, Spain;(34)Hospital Universitario del Henares, Gastroenterology, Coslada, Spain;(35)Hospital García Orcoyen, Gastroenterology, Estella, Spain;(36)Hospital General Universitario San Jorge, Gastroenterology, Huesca, Spain; On behalf of the Young Group of GETECCU. RESERVO Study Group: Baston I Rodríguez Lago I Baltar R Huguet JM Hermida B Caballero-Mateos A Sánchez-Guillén L Bouhmidi A Pajares R.

Background

Pouchitis and Crohn´s-like disease of the pouch (CDP) can be refractory to conventional therapy. Evidence of biological therapy has been rarely reported in large patient cohorts. We explored the use and effectiveness of these therapies and compared the success of a second biologic after antiTNF failure.

Methods

This is a retrospective RESERVO study of the Spanish cohort of GETECCU, that included patients operated for ulcerative colitis, with pouch construction, and subsequent diagnosis of pouchitis, CDP or cuffitis second ECCO diagnostic criteria1. Patients treated with antiTNF, Vedolizumab and/or Ustekinumab were selected. Clinical effectiveness was evaluated at long-term. We defined clinical remission as returning to the previous stool frequency, no pain or defecatory urgency, clinical response as the improvement in these parameters without the achievement of remission and non-response as no change or worsening of these symptoms. We also compared the effectiveness of second biologic (antiTNF vs vedolizumab-ustekinumab) after antiTNF failure, using descriptive and comparative statistics.

Results

The cohort comprised 145 patients. Demographic and clinical characteristics are represented in Table 1. A total of 232 biologic therapies were indicated. Of the total cohort, 60 (41.3%), 21 (14.4%) and 6 (4.1%) used two, three and four lines, respectively. Biologics used were Infliximab (n=95), Adalimumab (n=69), Vedolizumab (n=35), Ustekinumab (n=26) and Golimumab (n=7). Therapy characteristics, clinical effectiveness, need for intensification, discontinuation, and therapy duration for each biological therapy are represented in Table 2. Global rates of clinical remission, response, non-response and loss of response to a first biologic were 21.8%, 27.5%, 21.1% and 29.6%. Female gender was the only factor associated with effectiveness to a first biologic in univariate analysis (OR 2.16, CI 1.08-4.32, p 0.027). There were no significant differences regarding efectiveness between type of pouch disorder (pouchitis vs CDP, 51.6 vs 47.6%, p 0.48) or biologic agents. Thirty-nine patients received a second biologic after prior antiTNF failure (28 a second antiTNF and 11 non-antiTNF: 6 Vedolizumab, 5 Ustekinumab). Basal characteristics in this subgroup showed no significant differences. Clinical response (21.4 vs 63.6%, p 0.02) and discontinuation therapy rates (82.2 vs 54.5 %, p 0.04) after 11 months showed a more favorable profile for non-antiTNF therapy.


Conclusion

Biologics represent an effective option in the management of pouchitis and Crohn´s like disease of the pouch. Despite our small sample size, non-antiTNF therapy could be the best option after antiTNF failure. 

1Fernando Magro. J Crohns Colitis 2017; 11(6): 649–670.

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